Kornimate/medical-research-clean huggingface dataset:
naltrexone for overdose prevention

Conditions: Overdose Accidental

Summary: the goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine). the main questions it aims to answer are: what are the challenges for implementing naltrexone as an overdose prevention strategy? are injections of naltrexone effective for opioid overdose prevention among people who use stimulants? how often are people who use stimulants and do not intentionally use opioids unintentionally exposed to opioids? researchers will compare participants to receive the study medication to the usual care group to see if one group experiences fewer opioid overdose events than the other. participants will be randomized to either receive a monthly injection of naltrexone over six months, or receive usual care. usual care includes harm reduction supplies. laboratory procedures will include the collection of urine, blood, and hair samples for various safety and outcome measure testing.

this pilot randomized controlled trial aims to evaluate the efficacy of im naltrexone for opioid overdose prevention among individuals living with hiv (pwh) and those at risk for hiv who use stimulants. the study will concurrently collect data on the feasibility, acceptability, and preliminary effectiveness of the intervention, along with epidemiological data on the prevalence of both intentional and unintentional fentanyl exposure in this population. participants will be randomly assigned in a 1:1 fashion to either the intervention group, which will receive im naltrexone, or the usual care group, which will be provided with safe consumption supplies and intranasal naloxone. monthly assessments over a 24-week period post-intake (followed by a final study visit at 32 weeks) will be conducted to measure participants' exposure to fentanyl/opioids, utilizing both short-term (urine) and long-term (hair) biomarkers, as well as self-reported data. adherence to the monthly im naltrexone injections and the safety profile of the 'opioid prep' will also be rigorously evaluated.

Eligibility criteria:
inclusion criteria: 1. at-risk for hiv or living with hiv 2. stimulant use disorder (by dsm-v) or positive urine drug test for cocaine, amphetamine, or methamphetamine in last 6 months and report at least 10 days of stimulant use/month, 3. able to provide informed consent, 4. english-speaking, 5. age 18 years old or greater. exclusion criteria: 1. prescribed or non-prescribed opioid use (including newly diagnosed opioid use disorder by dsm-v), 2. receipt of long-acting injectable naltrexone for other indications in past 30 days, 3. planned surgery in next 6 months, 4. moderate, severe or chronic liver disease (ast, alt ≥ 5 times the upper limit of normal or symptoms of current liver disease), 5. persons who are pregnant or breastfeeding, 6. increased risk of bleeding (thrombocytopenia \<50 x 109/l, coagulopathy, or therapeutic anticoagulation), or 7. known hypersensitivity to naltrexone or its diluents.

Keywords: stimulants cocaine methamphetamine overdose prevention naltrexone fentanyl exposure
physical activity telehealth intervention after percutaneous coronary procedures

Conditions: Physical Activity

Summary: the purpose of this study is to test the feasibility of using targeted daily cell phone interaction to facilitate behavior change for physical activity in previously-sedentary individuals who have recently undergone a percutaneous coronary intervention (pci).

regular physical activity is important in the maintenance of cardiovascular health, and is especially critical for previously sedentary individuals who have undergone percutaneous coronary intervention (pci) procedures. changing behavior to adopt and maintain recommended physical activity levels in this population is difficult. interventions to accomplish behavior change will not work unless they can be adopted into a person's busy lifestyle. this proposed study fills a gap by testing the feasibility of an innovative, targeted intervention (physical activity promotion telehealth intervention), delivered by a practical and feasible platform (cell phone). the asynchronous targeted daily interaction will consist of 5-6 text, picture, and/or video messages delivered to the subject's cell phone each day. upon successful completion of this study, it is believed that these feasibility findings will provide a foundation for the testing of a larger clinical trial to promote physical activity in this population.

Eligibility criteria:
inclusion criteria: * first-time pci cardiac revascularization * age of 19 years or older * residing in a rural community * previously sedentary * physician approval to participate in this study * oriented to person, place, and time * able to see and hear (able to read the screen of a cell phone, and hear audio over a cell phone) * able to speak and read english. exclusion criteria: * residing in area of nebraska that does not have cell phone transmission * physical impairments limiting participation in physical activity and exercise following pci * evaluated by their physician to be too high risk for moderate physical activity as proposed in this study

Keywords: physical activity percutaneous coronary intervention heart disease
a new drug delivery system - silk fibroin film loaded or not with insulin on palatal mucosa wound healing

Conditions: Wound Healing; Insulin; Palate; Wound

Summary: the aim of the present study is to evaluate using clinical, patient-centered, immunological, microbiological, and histological parameters, the effect of silk fibroin films loaded or not with insulin in the repair of palatal mucosa open wounds.

there are several types of periodontal and peri-implant soft tissue defects that require surgical treatment to reestablishment function and aesthetics. therefore, surgical procedures for the reconstruction of the gingival and peri-implant tissues are routinely performed. however, these procedures do not always have predictable outcomes, and problems with the wound healing process can occur, which can impair the outcomes. to overcome this problem, new materials, drugs, and devices have been used to improve the results of surgical procedures. the present study is a controlled clinical trial that will include seventy-five patients with an indication of anterior maxillary tooth extraction for ridge preservation. the ridge preservation will be performed and a free gingival graft harvest from the palatal mucosa will be used to seal the socket entrance. thereafter, the palatal wound will be randomly assigned into 3 groups: control group (c; n=25): open wound on palatal mucosa that will receive no treatment. blank film group (bf; n=25): open wound on palatal mucosa that will receive silk fibroin film as dressing. insulin-loaded film (if; n=25): open wound on palatal mucosa that will receive an insulin-loaded silk fibroin film as a delivery system. clinical, immunological, histological, and microbiome parameters will be analyzed.

Eligibility criteria:
inclusion criteria: * patients with at least 18 years, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index less than 25% (ainamo, bay, 1975); * patients with no morphological or pathological conditions on the palatine donor area; * patients who present indication for extraction and ridge preservation; * the tooth included in the study, as well as, the adjacent teeth do not present loss of periodontal insertion; * patients who agreed to and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (resolution no. 118 - may, 2012, and ethics and code of professional conduct in dentistry - 118/12). exclusion criteria: * patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure; * patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure; * smokers patients; * pregnant or lactating patients; * patients who had had periodontal surgery on the study area; * patients who presents opportunistic oral lesions, mainly colonized the palate region; * use of dental prosthesis with palatal cover; * thin palatal mucosa (\~2.0mm).

Keywords: wound healing drug delivery system insulin fibroin
a study to assess the safety and tolerability of oxycodone hydrochloride 50mg/ml administered as an infusion

Conditions: Severe Caner Pain

Summary: assessing the safety and tolerability of oxycodone hydrochloride 50mg/ml in subjects with severe cancer pain.

this is study involving a treatment phase of up to 20 days. during this time patients will receive oxycodone hydrochloride 50mg/ml as a subcutaneous infusion. during the treatment phase, safety will be assessed by documentation of type and frequency of spontaneously reported adverse events and adverse events noted after assessment of the infusion site (every 24 hours and when resited). the subjects will be followed up for 7 days to collect information on ongoing aes/saes and any new aes/saes that may have occurred.

Eligibility criteria:
inclusion criteria 1. male or female subjects aged 18 years and above, who have severe cancer pain. 2. subjects who require a strong opioid by subcutaneous infusion to stabilise and manage their cancer pain effectively. 3. subjects who give written informed consent to participate in the study. 4. subjects who agree to their primary care physician being informed of their participation in the study. 5. subjects who consent to processing of their trial data according to the requirements of the uk data protection act 1998. exclusion criteria 1. subjects who are pregnant, lactating or in the investigators opinion are at risk of conceiving and are not using adequate contraception measures. 2. subjects with known hypersensitivity (allergic reaction) to oxycodone, any other opioids or any of the excipients. 3. subjects who are planned to receive chemotherapy during the study treatment period or are currently receiving continuous i.v. chemotherapy infusion. 4. subjects with neutropenia, thrombocytopenia or coagulation disorders. 5. subjects with any contraindications to oxycodone as outlined in the investigator brochure or summary product information sheet for oxycodone. 6. subjects who are currently participating in another clinical research study involving a new chemical entity. 7. subjects whom the investigator believes to be medically unfit to receive the study medication, or unsuitable for any other reason.

Keywords: oxycodone hydrochloride 50mg/ml observational infusion severe cancer pain
dyspnea, risk of falling and quality of life in adolescents, youth and geriatric groups

Conditions: Public Health

Summary: to assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the sf36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics.

an observational study was done to assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the sf36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics. the participants in each group were assessed using the previously mentioned scales. then the relationships between them were calculated and analyzed.

Eligibility criteria:
inclusion criteria: the participants were male or female community-dwellers, they ranged in age: adolescents from 12 to 17 years old, youth from 20 to 22 years old, and geriatrics from 60 to 80 years old. exclusion criteria: subjects with mobility disabilities and severe cognitive impairments.
a clinical trial to test how well two drugs, qaw039 and montelukast work both individually and together, to target allergic rhinitis using an environmental exposure chamber

Conditions: Allergic Rhinitis

Summary: this study will assess the safety and efficacy of qaw039 alone and in combination with montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure chamber.


Eligibility criteria:
inclusion criteria: * male or female aged 18-65 years inclusive, with a clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two grass pollen allergy seasons. * a positive skin prick test at visit 1 to dactylis glomerata with a wheal diameter equal to or greater than 3 mm and a negative control with a wheal diameter of zero. a positive skin prick test within 12 months prior to visit 1 is also acceptable. * fev1 measured by spirometry must be ≥80% of their predicted value at screening. if the patient does not achieve ≥80% of their predicted value this may be repeated prior to the eec challenge at visit 2. * tnss score ≥6 on at least one assessment during the 2h eec challenge at screening. exclusion criteria: * use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations. * pregnant or nursing (lactating) women, * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
awareness of deficit after combat-related brain injury

Conditions: Traumatic Brain Injury; Veterans

Summary: this study will use mri imaging, cognitive testing and outcome questionnaires to determine how the brain recovers and reorganizes after an injury.

the extent of recovery from brain injury is often difficult to predict because of our limited understanding of how the brain changes as it heals. new brain imaging methods may help in this regard. one imaging technique called functional magnetic resonance imaging (fmri) has made it possible to study the brain "at work"; that is, we can see regions of the brain that are active during particular tasks such as focusing attention, making decisions, or remembering words and pictures. another mri method called diffusion tensor imaging provides information on the pathways between brain regions that may be altered with brain injury. the goals of this research are to 1) determine the brain regions involved in making accurate judgments about one's abilities and disabilities after a brain injury and whether damage to these brain areas affects outcome; and 2) examine how recovery of cognitive and physical abilities relates to changes in brain function over time. in order to accomplish the first goal we will recruit veterans who have sustained a head injury and matched control subjects. for the second goal, we are asking patients and controls who have previously participated in brain injury research with our lab to come back for another visit at three years post-injury.

Eligibility criteria:
inclusion criteria: * history of traumatic brain injury at least 12 months prior to enrollment * control group: no history of traumatic brain injury exclusion criteria: * claustrophobia * metallic or electronic implants or devices that are not mri-safe * foreign metal, such as shrapnel, in the body

Keywords: recovery magnetic resonance imaging awareness neurologic deficits
assistance in neurosurgery (extempormn)

Conditions: Primary Brain Tumor; Glioma

Summary: the main ambition of this project is to develop, and provide the medical community, an innovative method to analyze extemporaneously, during a neurosurgery operation, excised tissues. this method is based on the analysis of the metabolic profile of excised tissues by the technique of high-resolution magic-angle spinning (hr-mas) nuclear magnetic resonance (nmr) spectroscopy. indeed hrmas nmr method can provide in a sufficiently short time lapse (currently about 30 minutes but within our project a time lapse of 15 min or even less is ultimately intended), medical information that can complement those obtained by classic histological examination. primary purpose: the main objective of this study is to determine the sensitivity of hrmas nmr spectroscopy in detecting residual tumor infiltration at the brain resection cavity. the investigators aim to determine the relevance of the metabolic analysis compared to histological analysis during a neurosurgery operation. this involves analyzing excised tissue samples, obtained from the operating rooms of strasbourg university hospitals, and colmar hospital center, with no return to neurosurgeon for surgery. secondary purposes: the secondary objectives of the protocol are to investigate the metabolome of different types of brain tumors, in order to find prognostic and diagnostic markers. it consists in detecting metabolomic factors of bad prognosis, and potential marker of good prognosis such as the idh mutation.


Eligibility criteria:
inclusion criteria: * male or female * age 18 years of age or older at the time of surgery * primary brain tumors (gliomas mainly) or epilepsy, for which neurosurgical intervention is programmed * in the case of brain tumors: primary-lesions or transformation of low-grade gliomas into high-grade gliomas not treated with radiotherapy * affiliated with a social security * having signed the informed consent * having been informed of the results of the medical examination prior exclusion criteria: * relapse of tumors previously treated with radiotherapy or chemotherapy * subject under treatment (radiotherapy or chemotherapy) prior to surgery * metastatic lesions (location of the primary lesion outside the central nervous system) * inability to give to the subject or his/her family enlightened information (subject in emergency situation, difficulties of understanding...) * subject under judicial protection * subject under guardianship or curatorship * patients' refusal

Keywords: high resolution magic angle spinning nuclear magnetic resonance nuclear magnetic resonance spectroscopy primary brain tumors gliomas extemporaneous analysis
hydra registry - italy experience

Conditions: Aortic Valve Stenosis

Summary: hydra-it is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of hydra tavi system in patient with severe aortic stenosis.

hydra-it is a multicenter observational study conducted across different centres in italy. the primary objective of the study is to evaluate the safety and efficacy of transcatheter aortic valve implantation and clinical outcome in patients treated with hydra device. secondary objective is to evaluate the long term (up to 5 years) effectiveness and the quality of treatment using hydra device. patients with severe stenosis symptomatic of the native aortic valve or bioprosthesis in a degenerated aortic position will be included in this study.

Eligibility criteria:
inclusion criteria: * patients with severe symptomatic native aortic valve stenosis and candidates for the tavi procedure based on the evaluation of the heart team * ability to understand and provide informed consent for inclusion in the study exclusion criteria: * contraindication to tavi: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis. * refusal by the patient to participate in the study * high probability of non-adherence to required follow-ups

Keywords: aortic valve stenosis tavi hydra
extended follow-up of treatment of prednisone plus cyclophosphamide in patients with advanced-stage iga nephropathy

Conditions: IgA Nephropathy

Summary: this study is an extended follow-up of the study (clinicaltrials.gov id: nct01758120)-treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage iga nephropathy.


Eligibility criteria:
inclusion criteria: * biopsy-proven primary iga nephropathy * 18-70 years old * elevated serum creatinine and less than 3.0mg/dl * with a written consent from participants to receive prednisone and/or cyclophosphamide exclusion criteria: * diabetes; * contraindications for the treatment of prednisone and/or cyclophosphamide * any treatment with steroids or immunosuppressive drugs prior to this study * acute deterioration of renal function(including those of glomerular origin)
study to assess safety, tolerability and phamacokinetics of kae609 administered intravenously in healthy subjects

Conditions: Malaria

Summary: this was a randomized, subject and investigator-blinded, placebo-controlled, single and multiple ascending intravenous (iv) dose study in healthy subjects to assess the safety and tolerability of kae609 given in the vein.

the study consisted of 2 parts: single-ascending dose (sad) part and multiple ascending dose (mad) part. in part a (single-ascending dose (sad) part), it was planned to recruit 6 active, 2 placebo subjects in each cohort: * cohort a1: 10.5 mg/placebo * cohort a2: 30 mg/placebo * cohort a3: 75 mg/placebo * cohort a4: 120 mg/placebo * cohort a5: 210 mg/placebo in part b (multiple-ascending dose (mad) part), subjects were assigned to one of the following treatment arms in a ratio of 2:1 (6 active, 3 placebo): * cohort b1: 60 mg/placebo, every 24 hours (q24h) × 5 days * cohort b2: 120 mg/placebo, every 24 hours (q24h) × 5 days eligible subjects were randomized to receive a single or q24h x 5 doses of either kae609 or placebo. safety, tolerability and pharmacokinetics were assessed over the period of 8 days for single dose and 12 days for multiple dose up to end of study visit for each subject.

Eligibility criteria:
key inclusion criteria: * healthy male and female subjects 18 to 55 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests. * subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (bmi) within the range of 18.0 - 30.0 kg/m2. key exclusion criteria: * use of other investigational drugs within 5 half-lives of screening, or within 30 days of dosing, whichever is longer; or longer if required by local regulations. * significant illness which has not resolved within two (2) weeks prior to initial dosing. * pregnant or nursing (lactating) women. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. * sexually active males unwilling to use a condom during intercourse while taking investigational drug and for at least 2 weeks after last dose of investigational drug.

Keywords: safety tolerability pharmacokinetics healthy volunteers phase 1 malaria intravenous iv kae609 placebo